Plain English Summary

Background and study aims Knee arthrosis occurs when the protective layer around the knee is damaged due to wear and tear, causing the bones to rub against each other. This causes pain and stiffness. There are a number of different treatment methods, such as taking anti-inflammatory (swelling) medications for pain relief. The medication can come in an ointment or in a tablet to be taken by mouth. However, taking tabulets by mouth can injury the digestive area, liver and kidneys. Using ointment may be a better option. The aim of this study is to compare the results of taking an anti-inflammatory medication called Loxoprofen Sodium Cataplasm as either an ointment or a tablet for the treatment of knee osteoarthritis.

Who can participate? Patients aged between 18 and 80 years Knee osteoarthritis

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group receive the treatment as an ointment that they apply once a day and a placebo (dummy) tablet three times a day. Those in the second group receive a placebo ointment and the medication as a tablet that is taken three times a day. This is done for four weeks. Participants are followed up to see if their symptoms have improved.

What are the possible benefits and risks of participating? After you participate this study, you can get better treatment for the knee osteoarthritis. At the same time, there exist some risks. The study drug may induce the drug adverse events. These drug adverse events may occur on you or not.

Where is the study run from? Peking University and People’s Hospital (China)

When is study starting and how long is it expected to run for? July 2010 to February 2012

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Patients with digestive ulcers 2. Patients with bronchial asthma 3. Patients with serious cardiac diseases, hepatic diseases (ALT, AST are equal or bigger than 2.5 times of upper limit), renal diseases (creatinine is equal or bigger than 1.5 times of upper limit), hematologic disease, diabetes, mental diseases, and other serious complications 4. Pregnant women, lactating women, patients with pregnancy potential, and patients who want to be pregnant during the clinical trial 5. Patients with drug hypersensitivity (aspirin asthma, hypersensitive to loxoprofen sodium or other drugs) 6. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis (dermatitis due to external agent or patients with dermatitis) 7. Patients combining other rheumatic diseases 8. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial 9. Patients participating any clinical trials on investigational drug or marketing drug within 3 months before inclusion or during clinical trial 10. Other patients judged to be inappropriate for this clinical trial by the investigator